Bar coding in the Blood Bank

Size: px
Start display at page:

Download "Bar coding in the Blood Bank"

Transcription

1 Bar coding in the Blood Bank for Ease, Speed + Accuracy Ann Mountain Wilson, TSO MUHC ICCBBA-GS1 International Meeting June 20, 2008

2 Bar coding in the blood bank Bar coded Blood components Non bar coded Plasma derivatives Significant difference in: Efficiency Time to enter & verify entry Risk of error Reading, interpreting, data entry, data verification Costs associated Low efficiency, error management & correction Patient safety Aspect of data accuracy & traceability

3 McGill University Health Centre Specialties include: Auto/Allo Bone marrow/stem cell transplant Solid organ transplant IgHepB Hematology/oncology Cardiovascular surgery Obstetrics RhIG Neurology / Neurosurgery IVIg, Tisseel Apheresis Albumin Specialized Pediatrics / Neonatology Albumin Neonatal/pediatric cardiac surgery & ECMO Thalessemia & Sickle Cell Centre Hemophilia centre Factors

4 Stable (Fractionated) Products Entry activity per year Activity # entries # vials # vials/entry Received , Issued 17,154 50,698 3 Returns 2,847 5,830 2 Total activity 22, ,200 5

5 Product information entered: Blood components Order # Invoice # Date of receipt Supplier Product code & name Manufacturer Donor # Expiry date Collection date Blood group Phenotype Attributes (details Allogenic / Autologous / Directed Volume 13 Fields: 2 sources of info Invoice Actual product (bar codes) Plasma derivatives Order # Invoice # Date of receipt Supplier Product code & name Manufacturer Lot # Expiry date IU / vial (coagulation factors Sub-vial lot #s (Tisseel) 8 Fields: 2 4 sources Invoice Product code Actual product Manufacturers date sheet Tisseel subvial lot # sheet

6 Xx Bar codes confirmation of administration from paper document not the product itself

7

8 No bar codes TIME Blood components Plasma derivatives Cost (22,500 vials/yr) Entry 13 sec / unit 60 sec / lot # 290 hrs / yr time (1 120 vials) = $7250 / yr

9 No bar codes Errors Product entry errors (reception / issuing etc.) Year Blood components Plasma derivatives Total April 2008 : TraceLine v9.4 (ISBT 128 compatible) Bar codes for attributes :CMV-, Irradiated, Directed Need to set defaults for product codes/attributes eliminated Bar codes Héma-Québec phenotype (needs verification)

10 Errors at the Blood Centre (HQ) Jan-June Similar lot # Wrong product delivered: IVIg 10g lot# 26N5KV1 et IVIg 5g lot# 26N5KW1 BayGam 2mL # 26N3WT1 et BayHepB 5mL # 26N53W1 Gammagard # VNE1A004 et Iveegam # VNE1A004A

11 Errors at the MUHC 2007 = 21 reported errors (18 of 21 database correction) 11 wrong lot numbers 5 wrong expiry dates 2 wrong product codes 1 wrong UI value for coagulation factor Jan-May 2008 = 7 errors 4 wrong lot numbers 3 wrong expiry dates **Includes reported events only. Errors corrected immediately are not be reported.

12 Database corrections Once moved, lab cannot modify data Database correction by supplier Cost : minimum $260 ($130 / hr x 2 hr (min) Risk of error during correction many vials affected at each status once moved Time to verify following correction. Temporary measures Quarantine until corrected Correct each issue voucher by hand to match vial (? s)

13 Database corrections 18 errors required database correction. Potential: 18 x $260 = $4680 per year Actual: 6 x $260 = $1560 per year Estimate ~36-40 errors requiring 15min to several hours to investigate and make appropriate correction. Estimate cost at $25/hour > $1000 per year Cost of frustration =???

14 Total cost Increased entry time = $7250 Supplier correction cost = $1560 Investigation & followup = $1000 Estimated cost ~ $10,000 / year

15 Errors impact on patient safety Expiry date (entered Dec 3) Nov 07: patient received expired Varizig exp, Mar 12 Traceability: Gammagard LE08G038AB vs LE08G038AD Dose: distributed 2 x *AB instead of 1 x *AB + 1 x *AD Detected by discrepancy in inventory following week Split the vials in system & entered portions into each potential recipient s file as possibly transfused in case of recall. IVIg 10g lot# 26N5KV1 et IVIg 5g lot# 26N5KW1

16 Date formats: mmm dd yyyy mmm-dd-yy mm yyyy yyyy mm dd m-d-yyyy d mmm aa mm/dd/yy dd mmm yyyy

17 Avoid long names Create product codes & names to fit most blood bank computer system windows.

18 Longer ISBT codes Shorten names to ensure pertinent info is legible in computer system windows.

19 Plasma derivatives to bar code: Product code & name limit length Manufacturer Lot numbers avoid O s & I s, & being too similar Tisseel sub-vial lot # on exterior packaging Expiry date standardize format IU per vial Get ready to enable bedside scanning To scan the actual product instead of voucher

20 Everyone makes mistakes.

21 Quality Assurance is about making it difficult to do it wrong and easy to do it right. Let s make it easy to do it right. by bar coding all products.

Paul Ashford Executive Director ICCBBA

Paul Ashford Executive Director ICCBBA Introduction to ISBT 128 Paul Ashford Executive Director ICCBBA ICCBBA ICCBBA enhances safety for patients by managing the ISBT 128 international information standard for use in transfusion and transplantation.

More information

Introduction to the ISBT 128 Labelling Standard for Blood Components

Introduction to the ISBT 128 Labelling Standard for Blood Components Introduction to the ISBT 128 Labelling Standard for Blood Components Hospital Transfusion Service Perspective What is ISBT 128? An international standard for the transfer of information associated with

More information

Introduction to the ISBT 128 Labelling Standard for Blood Components

Introduction to the ISBT 128 Labelling Standard for Blood Components Introduction to the ISBT 128 Labelling Standard for Blood Components Hospital IT Perspective What is ISBT 128? An international standard for the transfer of information associated with tissue transplantation,

More information

ISBT 128. An Introduction

ISBT 128. An Introduction ISBT 128 An Introduction ISBT 128 An Introduction 3 rd Edition - 2006 ISBT 128 An Introduction - 3rd Edition - 2006 1 Editorial Board Suzanne Butch, MA, MT(ASCP)SBB Ann Arbor, Michigan, USA Pat Distler,

More information

CELLULAR THERAPY SOLUTION. Streamline Your Program s Data Management from Start to Finish with Title21 Cellular Therapy Solution

CELLULAR THERAPY SOLUTION. Streamline Your Program s Data Management from Start to Finish with Title21 Cellular Therapy Solution CELLULAR THERAPY SOLUTION Streamline Your Program s Data Management from Start to Finish with Title21 Cellular Therapy Solution CELLULAR THERAPY SOLUTION PLATFORM Achieve paperless operations with one

More information

Implementing ISBT-128. Beryl Laird The Blood Center New Orleans, La.

Implementing ISBT-128. Beryl Laird The Blood Center New Orleans, La. Implementing ISBT-128 Beryl Laird The Blood Center New Orleans, La. History of ISBT International Society of Blood Transfusion (ISBT): Formed a Working Party on Automation and Data Processing Selected

More information

Irish Blood Transfusion Service Seirbhís Fuilaistriúcháin na héireann

Irish Blood Transfusion Service Seirbhís Fuilaistriúcháin na héireann Document Detail Irish Blood Transfusion Service Seirbhís Fuilaistriúcháin na héireann Type: Document No.: Title: PMF IBTS SPEC IBTS/PMF/SPEC/0201[2] PRODUCT MASTER FILE - GENERAL REQUIREMENTS Owner: 1066

More information

ISBT128 Standards for Blood and Blood Components: How it Translates to Patient Safety

ISBT128 Standards for Blood and Blood Components: How it Translates to Patient Safety ISBT128 Standards for Blood and Blood Components: How it Translates to Patient Safety Diana Teo Blood Services Group Health Sciences Authority Singapore 11/12/2010 1 All Rights Reserved 2008 Health Sciences

More information

ISBT 128 Labeling Overview. Fran Rabe University of Minnesota Molecular and Cellular Therapeutics

ISBT 128 Labeling Overview. Fran Rabe University of Minnesota Molecular and Cellular Therapeutics ISBT 128 Labeling Overview Fran Rabe University of Minnesota Molecular and Cellular Therapeutics ICCBBA u Not for profit organization u Formally: International Council for Commonality in Blood Banking

More information

Online Ordering System. Order and Inventory Management Training Manual v4.2

Online Ordering System. Order and Inventory Management Training Manual v4.2 Online Ordering System Order and Inventory Management Training Manual v4.2 Online Ordering System Logging In to BloodHub: Production/Live environment oneblood.bloodhub.com Validation/Training environment

More information

An overview of the Asia Pacific Blood Network and Overview of the status of plasma fractionation in the region

An overview of the Asia Pacific Blood Network and Overview of the status of plasma fractionation in the region An overview of the Asia Pacific Blood Network and Overview of the status of plasma fractionation in the region Overview» APBN Membership Vision and mission & strategic objectives Activities Plasma for

More information

Aim. To provide basic knowledge on the processing, testing and issue of blood donations by NHSBT

Aim. To provide basic knowledge on the processing, testing and issue of blood donations by NHSBT From Donor To Door Aim To provide basic knowledge on the processing, testing and issue of blood donations by NHSBT At the end of this session you will be aware of: The stages of processing, testing and

More information

Challenges In Cell Product Labeling, Tracking And Traceability

Challenges In Cell Product Labeling, Tracking And Traceability Challenges In Cell Product Labeling, Tracking And Traceability April 4-5, 2008 Columbus, Ohio Dave Krugh, MT(ASCP)SBB, CLS,CLCP(NCA) Clinical Program Manager, BMT Program Clinical Instructor, Department

More information

Good manufacturing practices

Good manufacturing practices ORIGINAL PAPER 1AR-10 ISBT Science Series (2009) 4, 6 10 Journal compilation 2009 International Society of Blood Transfusion Good manufacturing practices Blackwell Publishing Ltd A. Ahmed Quality Manager,

More information

United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128

United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 2.0.0 November 2005 United States Industry Consensus Standard for the Uniform Labeling

More information

ISBT 128 and the Single European Code

ISBT 128 and the Single European Code INTRODUCTION There is wide recognition of the need to standardise the terminology, coding and labelling of medical products of human origin (MPHO) in order to improve traceability and transparency. The

More information

HAEMOVIGILANCE. Ms. Emma O Riordan.

HAEMOVIGILANCE. Ms. Emma O Riordan. HAEMOVIGILANCE a set of surveillance procedures covering the whole transfusion chain from the collection of blood and its components to the follow-up of its recipients, intended to collect and assess information

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Puget Sound Blood

More information

ISBT 128 coding system and the Single European Code: Introduction. Presented by: Jessy Lardon

ISBT 128 coding system and the Single European Code: Introduction. Presented by: Jessy Lardon ISBT 128 coding system and the Single European Code: Introduction Presented by: Jessy Lardon Single European Code (= SEC) The SEC is the unique identifier applied to tissues and cells distributed in the

More information

STANDARD BLOOD PRODUCTS AND SERVICES

STANDARD BLOOD PRODUCTS AND SERVICES STANDARD BLOOD PRODUCTS AND SERVICES Policy NHP reimburses contracted providers for the medically necessary administration (transfusion) of blood and standard blood products. Prerequisites Authorization,

More information

Evolutionary implementation of GS1 standards in the area of medical devices at the University Clinical Center in Gdańsk

Evolutionary implementation of GS1 standards in the area of medical devices at the University Clinical Center in Gdańsk Evolutionary implementation of GS1 standards in the area of medical devices at the University Clinical Center in Gdańsk Medical supply department We organize the purchase and supply of medical devices

More information

Label Requirements for HCT/Ps

Label Requirements for HCT/Ps Label Design Label Requirements for HCT/Ps o Meet labeling principles o Suitable for Range of container sizes Range of storage temperatures/conditions Sequential addition of information o Eye and machine

More information

e-delphyn Blood Banking Information System

e-delphyn Blood Banking Information System e-delphyn Blood Banking Information System e-delphyn Blood Banking Information System offers a fully integrated blood banking information system with the following features: Blood Drive Administration

More information

6TH EDITION OF FACT-JACIE STANDARDS A QUICK SUMMARY. BHS JACIE Day, 6 March 2015 Eoin McGrath JACIE Operations Manager

6TH EDITION OF FACT-JACIE STANDARDS A QUICK SUMMARY. BHS JACIE Day, 6 March 2015 Eoin McGrath JACIE Operations Manager 6TH EDITION OF FACT-JACIE STANDARDS A QUICK SUMMARY BHS JACIE Day, 6 March 2015 Eoin McGrath JACIE Operations Manager CONTENTS Review process Sources of information Selection of main changes and developments

More information

ACT Plus. Automated Coagulation Timer. Precise, reliable the trusted standard.

ACT Plus. Automated Coagulation Timer. Precise, reliable the trusted standard. ACT Plus Automated Coagulation Timer Precise, reliable the trusted standard. THE TRUSTED STANDARD, FROM A COMPANY YOU TRUST Medtronic, the world s leading medical technology company and a key participant

More information

Looking after a Finite Resource. Adrian Ebbs Transfusion Laboratory Manager Queen Elizabeth Hospital King s Lynn

Looking after a Finite Resource. Adrian Ebbs Transfusion Laboratory Manager Queen Elizabeth Hospital King s Lynn Looking after a Finite Resource Adrian Ebbs Transfusion Laboratory Manager Queen Elizabeth Hospital King s Lynn Supply Chain Cold Chain Red Cells Platelets Blood Stocks Management Scheme Aim of Stock Management

More information

Information Sheet. A plasma contract fractionation program. General considerations

Information Sheet. A plasma contract fractionation program. General considerations Information Sheet Plasma Contract Fractionation Program General considerations The provision of safe and sufficient plasma derivatives to meet the needs of local populations in all countries reuires special

More information

BloodTrack. Remote blood inventory and bedside transfusion management system. software solutions

BloodTrack. Remote blood inventory and bedside transfusion management system. software solutions BloodTrack Remote blood inventory and bedside transfusion management system software solutions Optimal blood management Haemonetics is focused on helping optimize blood management by 1. Preventing a blood

More information

Alberta Health Services - Edmonton Zone Massive Hemorrhage Protocol

Alberta Health Services - Edmonton Zone Massive Hemorrhage Protocol This document applies to all Covenant and AHS sites. Client Resource 23: Alberta Health Services - Edmonton Zone Regional Laboratory Services This document is applicable at site(s): GNH MIS RAH SGH UAH

More information

Blood Product Utilization

Blood Product Utilization Who gets what & when Why not to give blood? Volume Expander For specific number (except as related to procedures) To patients with religious objections to blood transfusions Blood given only when necessary

More information

Hospital Experience. Mike Herbert - Transfusion Laboratory Manager New Cross Hospital Wolverhampton

Hospital Experience. Mike Herbert - Transfusion Laboratory Manager New Cross Hospital Wolverhampton Hospital Experience Mike Herbert - Transfusion Laboratory Manager New Cross Hospital Wolverhampton Blood Stocks Management Scheme 2016 Annual Road Show 8th June 2016 Birmingham Ten Top Tips Understand

More information

PLATELET GUIDANCE DOCUMENT

PLATELET GUIDANCE DOCUMENT Government of Newfoundland and Labrador Department of Health and Community Services Provincial Blood Coordinating Program PLATELET GUIDANCE DOCUMENT Office of Administrative Responsibility Director, Regional

More information

Blood Component Therapy and Apheresis

Blood Component Therapy and Apheresis Blood Component Therapy and Apheresis Dr. Debasish Gupta Program Director, CHF International TRANSFUSION THERAPY Used primarily to treat two conditions Inadequate oxygen carrying capacity because of anemia

More information

Producing Blood Components from donated Whole blood, or The art of the Impossible? Ian Symonds, Manufacturing Manager NHSBT Colindale

Producing Blood Components from donated Whole blood, or The art of the Impossible? Ian Symonds, Manufacturing Manager NHSBT Colindale Producing Blood Components from donated Whole blood, or The art of the Impossible? Ian Symonds, Manufacturing Manager NHSBT Colindale Where does the blood come from & where does it go? Nationally we have

More information

FMOL Health System UDI Capture Work Group Case Study

FMOL Health System UDI Capture Work Group Case Study LEARNING COMMUNITY FMOL Health System Capture Work Group Case Study WWW.AHRMM.ORG / LUC WORK GROUP TITLE: Capture Work Group CASE STUDY PARTICIPANTS James Phillips, Consulting Manager, DSI, the Office

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations 1 of 6 6/10/2009 10:36 AM Inspections, Compliance, Enforcement, and Criminal Investigations hhsbluebirddepartment of Health and Human Services Public Health Service Food and Drug Administration Dallas

More information

Recent FDA Inspection Findings and Trends

Recent FDA Inspection Findings and Trends Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11

More information

Apheresis Collection Fenwal Amicus Separator

Apheresis Collection Fenwal Amicus Separator Apheresis Collection Fenwal Amicus Separator Meeting your mission-critical goals PRECISION DESIGN TO HELP YOU ACHIEVE MORE Designed to deliver Amicus features technology that, combined with our expert

More information

Barcodes on Unit of Use

Barcodes on Unit of Use Barcodes on Unit of Use 1 What hospitals need Hospitals need medications Ready-to-Administer In Unit-of-Use With Barcode 2 What hospitals need Ready-to-Administer If not, must go through additional pharmacy

More information

Case Studies: Sharing Lessons Learned

Case Studies: Sharing Lessons Learned Case Studies: Sharing Lessons Learned Panel: Dennis Black, Director, e-business, BD Megan Brandt, VP Quality & Regulatory Affairs, Cardiovascular Systems, Inc. David Reed, VP Operations, Cook Medical Esther

More information

UDI 101: What You Need to Know About Unique Device Identifiers

UDI 101: What You Need to Know About Unique Device Identifiers UDI 101: What You Need to Know About Unique Device Identifiers Lena Cordie Qualitas Professional Services 2015 Qualitas Professional Services. All rights reserved. Presentation Objectives: Understanding

More information

Home truths... the clinical use of components in the UK. Jonathan Wallis. Platelets, FFP, Cryoprecipitate

Home truths... the clinical use of components in the UK. Jonathan Wallis. Platelets, FFP, Cryoprecipitate Home truths... the clinical use of components in the UK Platelets, FFP, Cryoprecipitate Jonathan Wallis Mar-01 Mar-02 Mar-03 Mar-04 Mar-05 Mar-06 Mar-07 Mar-08 Mar-09 Mar-10 Mar-11 Mar-12 E&N.Wales Platelet

More information

ABO, Rh, HLA Antibodies Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA

ABO, Rh, HLA Antibodies Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA ABO, Rh, HLA Antibodies Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA The Appeal of Whole Blood WHOLE BLOOD IN EXSANGUINATING

More information

ISBT 128 Implementation Experience

ISBT 128 Implementation Experience ISBT 128 Implementation Experience U. S. Army Kendrick Memorial Blood Center and Eisenhower Army Medical Center Fort Gordon, Georgia Josie Pippert MT(ASCP) Sarah Dailey MT(ASCP) Validation Protocol Army

More information

CURRENT COURSE OFFERINGS

CURRENT COURSE OFFERINGS The American Red Cross offers regular educational opportunities as a convenient way for healthcare providers to receive relevant blood banking and transfusion medicine information. The bi-monthly sessions,

More information

INTERNATIONAL SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2 & 3)

INTERNATIONAL SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2 & 3) PART I (TO BE COMPLETED BY APPLICANT) Applicant s Name Address Email Address PART II (MUST BE COMPLETED AND SIGNED BY LABORATORY MANAGEMENT* OR EMPLOYER IN ORDER TO BE ACCEPTABLE) SUBJECT: VERIFICATION

More information

EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS

EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS JUNE 2012 (UPDATED FROM 2007 & 2010 STATEMENTS) What is meant by barcoding of the single dose? By single dose EAHP

More information

Error Management and BPD Reporting for the Transfusion Service. Mary A Lieb MT(ASCP)SBB, CQA(ASQ) Director, Quality Source Blood Systems,

Error Management and BPD Reporting for the Transfusion Service. Mary A Lieb MT(ASCP)SBB, CQA(ASQ) Director, Quality Source Blood Systems, Error Management and BPD Reporting for the Transfusion Service Mary A Lieb MT(ASCP)SBB, CQA(ASQ) Director, Quality Source Blood Systems, Objectives Define biological product deviation Explain what constitutes

More information

INTERNATIONAL SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2 & 3)

INTERNATIONAL SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2 & 3) PART I (TO BE COMPLETED BY APPLICANT) Applicant s Name Address Email Address PART II (MUST BE COMPLETED AND SIGNED BY LABORATORY MANAGEMENT* OR EMPLOYER IN ORDER TO BE ACCEPTABLE) SUBJECT: VERIFICATION

More information

Why one size does NOT fit all. Presentation by: Nicola Main Date: 24 September 2013

Why one size does NOT fit all. Presentation by: Nicola Main Date: 24 September 2013 Why one size does NOT fit all Presentation by: Nicola Main Date: 24 September 2013 All of the information in this presentation is based on my own experience and knowledge. Other hospitals may have policies

More information

User Manual Verson SCM Only

User Manual Verson SCM Only ...Empowering people to make informed decisions. User Manual Verson 3.4 - SCM Only January 2013 Freely available from Futures Group Creative Commons License Contents 3 Table of Contents Foreword Part

More information

Global Registration Identifier for Donors (GRID) Overview

Global Registration Identifier for Donors (GRID) Overview Global Registration Identifier for Donors (GRID) Overview Martin Maiers Director, Bioinformatics Research National Marrow Donor Program/Be The Match CIBMTR On behalf of thewmda GRID Task Force GRID Overview

More information

Canadian Case Date Coding Industry Protocol

Canadian Case Date Coding Industry Protocol Canadian Case Date Coding Industry Protocol Agenda The Issue The Community The Recommendations and Timelines Next Steps 2 Issue Inability to perform efficient stock rotation due to lack of inconsistent

More information

SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2, 3, & 4)

SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2, 3, & 4) PART I (TO BE COMPLETED BY APPLICANT) Applicant s Name Last Four Digits of Applicant s Social Security # Address Email Address Daytime Telephone Number PART II (MUST BE COMPLETED AND SIGNED BY THE IMMEDIATE

More information

Serological Testing: Why we did what we did!

Serological Testing: Why we did what we did! Serological Testing: Why we did what we did! W. John Judd, FIBMS, MIBiol Emeritus Professor University of Michigan What we did Provided blood and blood products in a timely, cost-efficient manner. Implemented

More information

SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2, 3, & 4)

SPECIALIST IN BLOOD BANKING WORK EXPERIENCE DOCUMENTATION FORM (Routes 2, 3, & 4) PART I (TO BE COMPLETED BY APPLICANT) Applicant s Name Last Four Digits of Applicant s Social Security # Address Email Address Daytime Telephone Number PART II (MUST BE COMPLETED AND SIGNED BY THE IMMEDIATE

More information

Dennis Williams, MD Kentucky Blood Center University of Kentucky Dept. Path and Lab Med

Dennis Williams, MD Kentucky Blood Center University of Kentucky Dept. Path and Lab Med Dennis Williams, MD Kentucky Blood Center University of Kentucky Dept. Path and Lab Med None Disclosures Objectives 1) Describe the FDA Draft Guidance Background and Requirements 2) Review the responsibilities

More information

The World Health Assembly Resolution on availability, safety and quality of blood products (WHA 63.12) Adopted May 2010

The World Health Assembly Resolution on availability, safety and quality of blood products (WHA 63.12) Adopted May 2010 The World Health Assembly Resolution on availability, safety and quality of blood products (WHA 63.12) Adopted May 2010 Dr Ana Padilla Blood Products & related Biologicals Essential Medicines and Pharmaceutical

More information

Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia

Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia TITLE / DESCRIPTION: DEPARTMENT: Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia Surgical Services PERSONNEL:

More information

PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS

PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 005-2 1 July 2004 PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS PIC/S July 2004 Reproduction prohibited for commercial purposes.

More information

SPECIALIST IN BLOOD BANKING EXPERIENCE DOCUMENTATION FORM (Routes 2, 3 & 4)

SPECIALIST IN BLOOD BANKING EXPERIENCE DOCUMENTATION FORM (Routes 2, 3 & 4) PART I (To be completed by Applicant) SPECIALIST IN BLOOD BANKING EXPERIENCE DOCUMENTATION FORM (Routes 2, 3 & 4) Applicant s Name Last Four Digits of Applicant s Social Security # Address E-mail Address

More information

Report on Canada s Blood System. The Canadian Blood Services ***1/2

Report on Canada s Blood System. The Canadian Blood Services ***1/2 2003-2004 Report on Canada s Blood System 7 Years after The Commission of Inquiry on the Blood System in Canada Prepared by the Blood Safety Committee of the Canadian Hemophilia Society January 31, 2005

More information

2017 AABB Annual Meeting On-Demand SAM Sessions

2017 AABB Annual Meeting On-Demand SAM Sessions 2017 AABB Annual Meeting On-Demand SAM Sessions The following 14 SAM sessions from the 2017 AABB Annual Meeting are eligible for up to 17.75 SAM eligible credits. The number of credits is based on the

More information

Improving the Delivery of Transfusion Medicine Lab Services using ImmuLINK

Improving the Delivery of Transfusion Medicine Lab Services using ImmuLINK Improving the Delivery of Transfusion Medicine Lab Services using ImmuLINK Marian Fortmann MS,MT(ASCP)SBB Immucor User Group Meeting May 12, 2016 Boca Raton, FL Objectives Carolinas Healthcare System (CHS)

More information

STANDARD OPERATING PROCEDURE FOR ANTIBODY IDENTIFICATION - TUBE METHOD

STANDARD OPERATING PROCEDURE FOR ANTIBODY IDENTIFICATION - TUBE METHOD STANDARD OPERATING PROCEDURE FOR ANTIBODY IDENTIFICATION - TUBE METHOD TITLE: STANDARD OPERATING PROCEDURE FOR ANTIBODY IDENTIFICATION TUBE METHOD 1.0 Principle An antibody identification procedure is

More information

TRACK AND TRACE SOLUTIONS

TRACK AND TRACE SOLUTIONS TRACK AND TRACE SOLUTIONS Genealogy System The Need When considering i a product, traceability can relate to the origin of materials and parts the processing history the distribution and location o of

More information

Leadership in Immunology through Innovation, Global Execution, and Patient Support. Perry Sternberg, Head US Commercial

Leadership in Immunology through Innovation, Global Execution, and Patient Support. Perry Sternberg, Head US Commercial Leadership in Immunology through Innovation, Global Execution, and Patient Support Perry Sternberg, Head US Commercial Summary Shire is well positioned for further growth in Immunology Global immunology

More information

Massive Haemorrhage P Donnelly B Ferguson

Massive Haemorrhage P Donnelly B Ferguson Massive Haemorrhage P Donnelly B Ferguson What is Massive Haemorrhage (MH)? Difficult to apply rules as to how much blood loss defines a major haemorrhage. Easier to define how the patient s condition

More information

Sharon Tindle, MS, CQA (ASQ) QA Manager, BMT Tissue Services Mount Sinai Hospital, New York, NY. June 7, 2016

Sharon Tindle, MS, CQA (ASQ) QA Manager, BMT Tissue Services Mount Sinai Hospital, New York, NY. June 7, 2016 Sharon Tindle, MS, CQA (ASQ) QA Manager, BMT Tissue Services Mount Sinai Hospital, New York, NY June 7, 2016 1 Brief description of the Mount Sinai Cellular Therapy Laboratory Overview of BM transplant

More information

Performance by business line

Performance by business line Performance by business line Transfusable Products Transfusable Products includes all activities related to the supply of fresh blood products to hospitals, including donor recruitment, collection of whole

More information

GUIDELINES FOR IDENTIFICATION AND INDICATION OF BLOOD COMPONENTS AND BLOOD PRODUCTS.

GUIDELINES FOR IDENTIFICATION AND INDICATION OF BLOOD COMPONENTS AND BLOOD PRODUCTS. GUIDELINES FOR IDENTIFICATION AND INDICATION OF BLOOD COMPONENTS AND BLOOD PRODUCTS. Hur sluta röka cold turkey 1. Policy Statement The Regional Health Authorities should develop policies that: 1.1 Provide

More information

Re: Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria: Interoperability Updates and Regulatory Improvements

Re: Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria: Interoperability Updates and Regulatory Improvements April 28, 2014 Filed Electronically: http://www.regulations.gov Department of Health and Human Services Office of the National Coordinator for Health Information Technology Attention: 2015 Edition EHR

More information

Track & Trace System for Coagulation Factor Concentrates used in Ireland

Track & Trace System for Coagulation Factor Concentrates used in Ireland Track & Trace System for Coagulation Factor Concentrates t used in Ireland Evelyn Singleton, National Co-ordinator for Coagulation Factor Concentrates, National Centre for Hereditary Coagulation Disorders,

More information

Niccolo Machiavelli (1523)

Niccolo Machiavelli (1523) Nothing is more difficult to undertake, more perilous to conduct or more uncertain in its outcome, than to take the lead in introducing a new order of things. For the innovator has for enemies all those

More information

ISBT 128 Labels for CT

ISBT 128 Labels for CT ISBT 128 Labels for CT Implementation: System Design, Development, Changes, and Challenges: Part Deux Kathryn M. Bushnell Technical Specialist Cellular Therapy Center WORKSHOP OBJECTIVES Provide information

More information

TRACEABILITY USER MANUAL

TRACEABILITY USER MANUAL BT No.: 0425 Ver. 6 IRISH BLOOD TRANSFUSION SERVICE TITLE: TRACEABILITY USER MANUAL Supersedes Version: 5 Change Description: Revise BT - 0425. Update traceability user manual. In section 4.7 include re-routing

More information

HCT/P Deviations & Reporting. 13 th ANNUAL FDA & The Changing Paradigm for HCT/P Regulation February 13-15, 2017

HCT/P Deviations & Reporting. 13 th ANNUAL FDA & The Changing Paradigm for HCT/P Regulation February 13-15, 2017 HCT/P Deviations & Reporting CASE STUDIES FROM TISSUE AND EYE BANKS AND CELLULAR THERAPY. 13 th ANNUAL FDA & The Changing Paradigm for HCT/P Regulation February 13-15, 2017 Tissue Bank Perspective Ashley

More information

Requirements of IBTO (AABB) Standards d for a Blood Transfusion Request 1.Positive identification of the recipient and the recipient blood samples.

Requirements of IBTO (AABB) Standards d for a Blood Transfusion Request 1.Positive identification of the recipient and the recipient blood samples. Detection and Identification of alloantibodies to Red Cell Antigens Antibody Screen Test Iranian Blood Transfusion Organization Mostafa Moghaddam MS, CLS ( ASCP ) BB Head of Immunohematology Reference

More information

BIOLOG TRANSFUSION TRANSFUSION RFID BLOOD SUPPLY MANAGEMENT. Connecting healthcare to empower people

BIOLOG TRANSFUSION TRANSFUSION RFID BLOOD SUPPLY MANAGEMENT. Connecting healthcare to empower people TRANSFUSION Connecting healthcare to empower people BLOOD SUPPLY MANAGEMENT RFID SMART STORAGE KITS (SST) Designed for industry-standard blood component storage Refrigerators (SST-R), Freezers (SST-F)

More information

OBSERVATIONS AND ANSWERS

OBSERVATIONS AND ANSWERS OBSERVATIONS AND ANSWERS PRODUCTION CONTROL C.02.012 1. Following the review of recall files, it was noted as documented on form LSC-ENR-002 that there has been a 1 to 3 days delay before the final disposition

More information

Two-Dimensional (2D) Vaccine Barcode Pilot Project

Two-Dimensional (2D) Vaccine Barcode Pilot Project Two-Dimensional (2D) Vaccine Barcode Pilot Project Association of Immunization Managers / Immunization Program Managers Meeting February 3, 2012 Ken Gerlach, MPH, CTR Immunization Services Division National

More information

Single European Code for Tissues and Cells

Single European Code for Tissues and Cells Single European Code for Tissues and Cells Mr Richard Forde, Blood Tissues and Organs Inspector Health Products Regulatory Authority 17 th, HPRA Offices Overview: The Single European Code (SEC): Legislative

More information

Terminology Group. Cellular Therapy Coding & Labeling Advisory Group

Terminology Group. Cellular Therapy Coding & Labeling Advisory Group Terminology Group Task Group Members Alan Lankester Pat Distler Derwood Pamphilon Leigh Poston Kathy Loper Ineke Slaper-Cortenbach Phyllis Warkentin Assignment Review existing definitions in ISBT 128 data

More information

TALYST: Enterprise Wide Pharmacy Solutions

TALYST: Enterprise Wide Pharmacy Solutions TALYST: Enterprise Wide Pharmacy Solutions TALYST: Engineering the Safer and More Cost Effective Pharmacy About Us Talyst is the market leader in central pharmacy automation and your expert partner in

More information

NHS Blood and Transplant Reagents. Meeting your serology needs

NHS Blood and Transplant Reagents. Meeting your serology needs NHS Blood and Transplant Reagents Meeting your serology needs NHSBT Reagents meet your serology needs by manufacturing a portfolio of transfusion related diagnostic reagents, supporting our commercial

More information

Transmitting Data to Your Customers through the GDSN. March 14, 2013

Transmitting Data to Your Customers through the GDSN. March 14, 2013 Transmitting Data to Your Customers through the GDSN March 14, 2013 Agenda Background on 1Worldsync GS1 US and 1WorldSync in Health Care GS1 US and 1WorldSync in Foodservice Who is driving this request

More information

Vaccine traceability in Tanzania. Brian Taliesin Director of Project Management & Knowledge Management 09-May-2018

Vaccine traceability in Tanzania. Brian Taliesin Director of Project Management & Knowledge Management 09-May-2018 Vaccine traceability in Tanzania Brian Taliesin Director of Project Management & Knowledge Management 09-May-2018 Barcode use showing demonstrated benefits but barriers remain Benefits Reduction in Excess

More information

PROVINCIAL BLOOD COORDINATING PROGRAM DEFINITIONS NLBCP-063

PROVINCIAL BLOOD COORDINATING PROGRAM DEFINITIONS NLBCP-063 Government of Newfoundland and Labrador Department of Health and Community Services Provincial Blood Coordinating Program PROVINCIAL BLOOD COORDINATING PROGRAM DEFINITIONS Office of Administrative Responsibility

More information

GS1 African Healthcare Conference

GS1 African Healthcare Conference GS1 African Healthcare Conference Traceability and verification of anti-malarial commodities in the Ethiopian supply chain Teddy Berihun, Senior Health Information Systems Adviser USAID, Ethiopia Al Shiferaw,

More information

The Long Road to Haemonetics. March 2015 Nada Nsier Transfusion Safety Coordinator Kristin Yanitski and Molly Ortlieb Tech I Kathy Hamacher Tech III

The Long Road to Haemonetics. March 2015 Nada Nsier Transfusion Safety Coordinator Kristin Yanitski and Molly Ortlieb Tech I Kathy Hamacher Tech III The Long Road to Haemonetics March 2015 Nada Nsier Transfusion Safety Coordinator Kristin Yanitski and Molly Ortlieb Tech I Kathy Hamacher Tech III 1 Who Collaboration between Laboratory Medicine, Kaye

More information

License Submission Checklist for Platelets, Leukocytes Reduced Collected by Pheresis

License Submission Checklist for Platelets, Leukocytes Reduced Collected by Pheresis License Submission Checklist for Platelets, Leukocytes Reduced Collected by Pheresis Purpose: To provide guidance when submitting documentation to FDA in support of a BLA or a license supplement. Definitions

More information

Platelet Refractoriness: The Basics. Martin H. Bluth, MD, PhD

Platelet Refractoriness: The Basics. Martin H. Bluth, MD, PhD Platelet Refractoriness: The Basics Martin H. Bluth, MD, PhD Complete Toxicology Laboratories, LLC Objectives Define platelet refractoriness and associated conditions that may cause platelet refractoriness.

More information

Saudi Drug Code (SDC), and Drug Barcoding Specifications

Saudi Drug Code (SDC), and Drug Barcoding Specifications Drug Sector Licensing Executive Directorate Guidance for Industry Saudi Drug Code (SDC), and Drug Barcoding Specifications This document outlines the SDC and the new drug barcode requirements for pharmaceuticals.

More information

GUIDELINES FOR ISSUING AND RETURNING BLOOD COMPONENTS AND BLOOD PRODUCTS WITHIN A FACILITY

GUIDELINES FOR ISSUING AND RETURNING BLOOD COMPONENTS AND BLOOD PRODUCTS WITHIN A FACILITY GUIDELINES FOR ISSUING AND RETURNING BLOOD COMPONENTS AND BLOOD PRODUCTS WITHIN A FACILITY 1. Policy Statement 1.1 A policy shall be in place to ensure traceability of all blood components and blood products

More information

Increasing Efficiencies in the Blood Supply Chain by Reducing Hospital Red Cell Wastage. Judith Chapman Blood Stocks Management Scheme, London

Increasing Efficiencies in the Blood Supply Chain by Reducing Hospital Red Cell Wastage. Judith Chapman Blood Stocks Management Scheme, London Increasing Efficiencies in the Blood Supply Chain by Reducing Hospital Red Cell Wastage Judith Chapman Blood Stocks Management Scheme, London Presentation Outline Monitoring blood supply management in

More information

What To Do or Not To Do? Utility of Medication Traceability to the Patient

What To Do or Not To Do? Utility of Medication Traceability to the Patient What To Do or Not To Do? Utility of Medication Traceability to the Patient Melsen Kwong, Pharm.D. Associate Director Department of Pharmacy Services Cedars-Sinai Medical Center, Los Angeles, CA, USA Objectives

More information

Disclosures. Objectives 9/16/2015. Pharmacy Sterile Compounding: Quality, Technology and Robots..Oh My!

Disclosures. Objectives 9/16/2015. Pharmacy Sterile Compounding: Quality, Technology and Robots..Oh My! Disclosures Pharmacy Sterile Compounding: Quality, Technology and Robots..Oh My! Caryn Belisle declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or

More information

Meeting UDI-requirements - Lessons Learnt and Customer Perspective LSA2018

Meeting UDI-requirements - Lessons Learnt and Customer Perspective LSA2018 Meeting UDI-requirements - Lessons Learnt and Customer Perspective LSA2018 Sylvia Reingardt, Senior Sector Manager Healthcare, GS1 Germany July 4, 2018 MediaDocks Lübeck Disclaimer Neither GS1 nor its

More information

Healthcare. Applying GS1 Standards for DSCSA and Traceability. Addendum: Diagrams and XML Examples for Serialized Exceptions Processing

Healthcare. Applying GS1 Standards for DSCSA and Traceability. Addendum: Diagrams and XML Examples for Serialized Exceptions Processing Healthcare Applying GS1 Standards for DSCSA and Traceability Addendum: Diagrams and XML Examples for Serialized Exceptions Processing Release 1.2, Nov 08 2016 TM Table of Contents 1 Introduction... 6 1.1

More information

Vein-to-Vein: Creating New Products to Optimize Patient Outcomes

Vein-to-Vein: Creating New Products to Optimize Patient Outcomes Vein-to-Vein: Creating New Products to Optimize Patient Outcomes BETH H. SHAZ, MD CHIEF MEDICAL AND SCIENTIFIC OFFICER EXECUTIVE VICE PRESIDENT NEW YORK BLOOD CENTER N Y B C. O R G S A V E A L I F E N

More information